A Phase 3 interventional study of Exercise and Respiratory Training in Chronic Pulmonary Hypertension, sponsored by Heidelberg University. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-07-02.
Sponsored by Heidelberg University · Phase 3, Interventional, and Treatment
Background
-Pulmonary hypertension (PH) is associated with restricted physical capacity, limited quality of life, and a poor prognosis because of right heart failure. The present study is the first prospective randomized study to evaluate the effects of exercise and respiratory training in patients with severe symptomatic PH.
Methods
-Patients with PH on stable disease-targeted medication will be randomly assigned to a control and a primary training group. Medication will remain unchanged during the study period. Primary end points will be the changes from baseline to week 15 in the distance walked in 6 minutes and in scores of the Short Form Health Survey quality-of-life questionnaire. Changes in WHO functional class, Borg scale, and parameters of echocardiography and gas exchange also will be assessed.
Prospects
-We hope this study will indicate that respiratory and physical training are a promising adjunct to medical treatment in severe PH.
Heidelberg University is the lead sponsor of 287 studies on the registry; 19 are open to participants now.
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Additional inclusion criteria will be age of between 18 and 75 years and World Health Organization (WHO) functional class II to IV.
Exclusion Criteria:
Behavioral: Exercise and Respiratory Training
Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.
distance walked in 6 minutes
Time frame: baseline - 15 weeks afterwards
change in quality of life as measured by the Short Form Health Survey (SF-36) questionnaire
Time frame: baseline - 15 weeks afterwards
changes in WHO functional classification
Time frame: baseline - 15 weeks afterwards
Borg scale assessed immediately after completion of the stress Doppler echocardiography
Time frame: baseline - 15 weeks afterwards
parameters of echocardiography
Time frame: baseline - 15 weeks afterwards
parameters of gas exchange
Time frame: baseline - 15 weeks afterwards
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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